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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Senators on both sides of the aisle are trying to incentivize the development of new drugs for newborn babies and medical countermeasures via a new exclusivity voucher and a priority review voucher system that are similar to the voucher programs already linked to tropical and rare pediatric disease treatments.

Sponsors awarded the voucher would be entitled "to one year of transferable extension of all existing patents and marketing exclusivities, including any extensions, for a single human drug with respect to an application submitted under section 505(b)(1) or for a single human biologic product with respect to an application submitted under section 351(a) of the Public Health Service Act."

And similarly to the vouchers for tropical disease and rare pediatric disease treatments, the neonatal exclusivity voucher is transferable, meaning companies can buy and sell them. The market for such vouchers has been a lucrative one, with AbbVie most recently paying $350M for a rare pediatric disease voucher awarded to United Therapeutics.

As the FDA Law Blog notes, Sen. Casey "has taken a pinch of the PRV [priority review voucher] and a pinch of the concepts underlying 'wildcard exclusivity,' mixed them together, and came up with something new."

The bill also adds a stipulation that the vouchers cannot be combined with others to prolong a drug's exclusivity even further.

And eight years after the date of enactment of the bill, or on the date that the third neonatal exclusivity voucher is awarded, whichever is earlier, the Comptroller General of the US will conduct a study of the effectiveness of the program.

Medical Countermeasures

In addition to the neonatal drug exclusivity voucher, Sen. Richard Burr (R-NC) also introduced a bill, known as the Medical Countermeasure Innovation Act of 2015, which would effectively create a new priority review voucher program modeled off the older priority review voucher programs for tropical and rare pediatric diseases.

Like its predecessors, the medical countermeasure vouchers would entitle sponsors to an expedited six-month review, rather than the standard 10-month review, though it would be only for sponsors "of a material threat medical countermeasure application."

Medical countermeasures are defined as FDA-regulated products (biologics, drugs, devices) that may be used in the event of a public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, a naturally occurring emerging disease, or a natural disaster.

The medical countermeasure vouchers would also be transferrable, require 90-day notice to FDA before use and are subject to a priority review user fee.

Pushback

The moves to extend the use of vouchers for new treatments would seem to be an indication that the previous priority review voucher systems have been a success. However, in an interview with the RPM Report, FDA Office of New Drugs Director John Jenkins expressed concerns "that have been amplified now that more vouchers have been issued" and are beginning to be redeemed.

"Reviewing such an application in 6 months is very challenging and has the adverse impact of requiring managers andreviewers to refocus time and resources away from other important public health work," Jenkins said.

Similarly, Aaron Kesselheim, professor of Medicine at Harvard, recently raised questions about the utility of the priority review voucher programs. And now that the vouchers for tropical diseases have been available for seven years, he's raising new questions about whether the voucher system actually works, or whether it needs to be redesigned.